Bytes and Pieces

Supplements can be confusing, and there are lots of rumors going around about their safety and what they can do for you. You can get the facts here!

Did you know…

• According to the U.S. Food and Drug Association (FDA), the definition of dietary supplement is:
  • A product other than tobacco that is intended to supplement the diet, contains one or more dietary ingredient or their constituents, is intended to be taken by mouth as a pill, capsule, tablet, or liquid, and is labeled on the front panel as being a dietary supplement.

• Ingredients that were used in dietary supplements before October 15, 1994 were and are considered safe, while evidence of safety and effectiveness must be provided to the FDA for new dietary ingredients added since that time.

• Dietary ingredients found in supplements include:
  • Vitamins
  • Minerals
  • Herbs
  • Other botanicals
  • Amino acids
  • Other substances

• Dietary supplements are not regulated by the FDA in the same way as food and drugs. Whether something is considered a food, drug, or dietary supplement depends on its intended use. Indicating the intended use of dietary supplements is the responsibility of the manufacturer.

• Manufacturers of dietary supplements are NOT allowed to claim their product can:
  • Diagnose
  • Cure
  • Mitigate
  • Treat
  • Prevent…a disease

• A dietary supplement may contain any of the following claims:
• • Health claim – describes the relationship between a food, food-component, or dietary supplement ingredient and reducing the risk for a disease or health-related condition.
  • Nutrient content claim – describes the relative amount of a nutrient or dietary substance in a product.
  • Structure/function claim – describes how a product may affect the organs or systems of the body without mentioning a specific disease.

• Structure/Function claims on dietary supplement labels do not need to be approved by the FDA, but must come with the following disclaimer:
  • “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.”

• Before placing a product on the market, a dietary supplement manufacturer must:
  • Provide convincing evidence to the FDA the product is safe and effective.
  • Provide a label that is truthful and not misleading.

• All of the following are required to appear on the dietary supplement label:
  • Name of product (including the word “supplement” or equivalent)
  • Net quantity of contents
  • Name and place of business of manufacturer, packer, or distributor
  • Directions for use
  • Serving size, list of dietary ingredients, amount per serving size, percent of daily value (DV), if established
  • If a botanical, the scientific name or common standardized name of the plant and the name of the plant part used
  • If a propriety blend (blend exclusive to manufacturer), the total weight and components in order by predominance by weight
  • Nondietary ingredients such as fillers, artificial colors, sweeteners, flavors, or binders listed by weight in descending order by predominance and by common name or propriety blend
• A manufacturer is NOT required to include a cautionary statement on the dietary supplement label
• Quality control of dietary supplements depends on the manufacturer, but as of 2007, when the FDA issued a set of requirements and expectations called Good Manufacturing Practices (GMP), all manufacturers of dietary supplements are expected to guarantee the identity, purity, strength, and composition of their dietary supplements.
• GMPs aim to prevent the inclusion of the wrong ingredients, the addition of too much or too little of a dietary ingredient, the possibility of contamination (by pesticides, heavy metals such as lead, bacteria, etc.), and the improper packaging and labeling of a product.
• Dietary supplements are not standardized in the United States. Standardization of dietary supplements is a way the manufacturers ensure batch-by-batch consistency, and there is no legal definition of standardization in the U.S. that applies to dietary supplements. This may lead to manufacturers using the word “standardized” incorrectly to signify product quality.